(79 days)
The PROBEAT-V with X-ray Limiting Accessory is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
The PROBEAT-V with X-ray Limiting Accessory is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment.
The X-ray Beam Limiting accessory for use in conjunction with the cleared PROBEAT-V system is designed to limit the patient's X-ray exposure during for patient positioning with the Cone Beam CT (CBCT). The device has 4 motorized leaves which are controlled by the PROBEAT-V imaging software to position the leaves in order to limit the patient's radiation exposure during patient positioning.
The provided text describes a 510(k) premarket notification for the PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and detailed performance data on the X-ray Limiting Accessory itself.
Based on the provided information, I can extract the following:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with numerical targets. Instead, it states that "In all cases, the device performed as intended and met all pre-specified success criteria." The performance evaluation focused on the integration of the X-ray Beam Limiting Device with the PROBEAT-V system.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Slice Pitch Accuracy | Met all pre-specified success criteria and performed as intended. |
| Spatial Accuracy | Met all pre-specified success criteria and performed as intended. |
| Spatial Resolution | Met all pre-specified success criteria and performed as intended. |
| Isocenter Accuracy | Met all pre-specified success criteria and performed as intended. |
| Performance with Proton Beam Therapy Positioning System | Met all pre-specified success criteria and performed as intended. |
| Electrical Safety | Evaluated and met all pre-specified success criteria and performed as intended. |
| Electromagnetic Compatibility | Performed and met all pre-specified success criteria and performed as intended. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on sample sizes for the test set or data provenance (country of origin, retrospective/prospective). The testing appears to be a validation of the integrated system in an engineering and performance testing context rather than a clinical study with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The testing described appears to be technical performance testing of the device itself (e.g., accuracy, resolution, safety) and not a diagnostic or therapeutic output requiring interpretation by medical experts to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The testing described appears to be technical performance testing of the device itself and not a diagnostic or therapeutic output requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document describes a proton beam therapy system with an X-ray limiting accessory, not an AI-based diagnostic or therapeutic assistance system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the device's X-ray limiting accessory and its integration with the PROBEAT-V system. The "Performance Data" section describes this standalone performance testing for the integrated system, including slice pitch accuracy, spatial accuracy, spatial resolution, isocenter accuracy, and performance with the proton beam therapy positioning system, as well as electrical safety and electromagnetic compatibility. The device performed as intended and met all pre-specified success criteria in these tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical performance tests mentioned (slice pitch accuracy, spatial accuracy, etc.), the "ground truth" would be established by validated measurement standards and reference devices used in engineering and quality control, rather than clinical ground truth like pathology or expert consensus. For electrical safety and electromagnetic compatibility, the ground truth would be compliance with relevant international and national standards.
8. The sample size for the training set
Not applicable for this type of device and submission. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable for this type of device and submission. This is not an AI/machine learning device requiring a training set.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.